CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTS, MARKED BY [***], HAS BEEN OMITTED BECAUSE BOLT BIOTHERAPEUTICS, INC. HAS DETE RMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO BOLT BIOTHERAPEUTICS, INC. IF PUBLICLY DISCLOSED.
2.3 “API/Drug Substance” means the active pharmaceutical ingredient or any intermediate thereof, in each case identified in a Statement of Work.
2.4 “Applicable Law” means all ordinances, rules, regulations, laws, guidelines, guidances, and requirements of any Authority that apply to the Services and the activities contemplated under this Agreement, and any other applicable laws and regulations, as amended from time to time.
2.5 “Authority” means any government or regulatory authority with jurisdiction over the Manufacture of Product or use of Product in the intended country of use, including, without limitation, the FDA, PMDA, MHRA and the EMA.
2.6 “Batch” means a specific quantity of Product that is intended to be of uniform character and quality and is produced during the same cycle of Manufacture as defined by the applicable Batch record.
2.7 “Batch Documentation” means the documents and other records that are produced in connection with the Manufacture of a particular Batch and/or lot.
2.8 “Bolt Indemnitee” has the meaning set forth in Section 14.1.
2.9 “Bolt Materials” means the materials identified in a Statement of Work as being provided by Bolt or its designee, including the original materials, together with any derivatives, progeny, or improvements developed therefrom, and any combination of the foregoing with other substances. For clarity, Bolt Materials shall include any and all intermediates (antibody or small molecule).
2.10 “Bolt Technology” means (a) Bolt Materials, (b) Product, (c) Specifications, (d) the Technology owned by or licensed to Bolt (i) prior to the Effective Date, or (ii) after the Effective Date independently of this Agreement, and (e) the Manufacturing Process except to the extent such process includes Piramal Technology.
2.11 “Certificate of Analysis” means a document, signed by an authorized, quality assurance representative of Piramal and Piramal’s Qualified Person, describing Specifications for, and testing methods applied to, Product, and the results thereof.
2.12 “Certificate of Compliance” means a document, signed by an authorized, quality assurance representative of Piramal and Piramal’ s Qualified Person, attesting that a particular Batch was Manufactured in accordance with cGMP, Applicable Law, and the Specifications.
2.13 “cGMP” means the current good manufacturing practices applicable to the Manufacture of Product pursuant to Applicable Law, including but not limited to the Current Good Manufacturing Practice Regulations of the United States Code of Federal Regulations 21 CFR Parts 210 and 211 and the European Community Directive 2003/94/EC (Principles and Guidelines of Good Manufacturing Practice for Medicinal Products), as well as the applicable documents developed by the International Conference on Harmonization (ICH), in effect as of the date of Manufacture of a particular Batch of Product.
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